Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil

This is a national retrospective cohort study with internet-based recruitment which intends to enroll 1,694 adult patients with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil. Participants with confirmed symptomatic COVID-19 after january 2022 will be evaluated in order to assess incidence, potential risk factors and impact of post COVID-19 condition according to the WHO definition on health-related quality of life and other relevant patient-centered outcomes.

Study Overview

• Status: Recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Other: Multiple exposures

• Study Type: Observational
• Enrollment (Estimated): 1694

Contacts and Locations

• Study Contact: Name: Maicon Falavigna, MD, PhD; Phone Number: +5551994408818; Email: maicon@inovamedical.com.br
• Study Contact Backup: Name: Régis G Rosa, MD, PhD; Phone Number: +5551991303877; Email: regis@inovamedical.com.br

Study Locations

• Brazil
  • RS
    • Cachoeirinha, RS, Brazil
      • Recruiting
      • Inova Medical
      • Contact: Maicon Falavigna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study target population is composed by adult participants with confirmed symptomatic COVID-19 during the SARS-CoV-2 omicron wave in Brazil (January 2022 to date, representing the period of time with absolute dominance of omicron as circulating variant). The study will include patients with distinct levels of acute illness severity (i.e., both outpatients and patients who required hospitalization for COVID-19).

Description

Inclusion Criteria:

• Age ≥ 18 years;
• Brazilian resident;
• Symptomatica COVID-19 confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test for SARS-COV-2 after January 2022, with diagnosis at least 90 days before recruitment.

Exclusion Criteria:

• No availability to participate in remote research appointments;
• Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
• Refuse to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil	Other: Multiple exposures; Exposures variables (observational study): age, gender, education, comorbidities, vaccination status, severity of the acute episode of COVID-19, treatments used for acute COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post COVID-19 condition according to the WHO definition	Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis	3 to 24 months
EQ5D-3L	Health-related quality of life assessed using the EuroQol five-dimensional 3-level descriptive system (EQ5D-3L). This outcome will be considered as primary when Post COVID-19 condition be used as exposure.	3 to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrumental activities of daily living	Instrumental activities of daily living assessed with the Lawton & Brody Instrumental Activities of Daily Living	3 to 24 months
Functional status	Functional status assessed with the Modified Barthel Index	3 to 24 months
Cognition	Cognition assessed with the Telephone Interview for Cognitive Status	3 to 24 months
Anxiety symptoms	Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;	3 to 24 months
Depression symptoms	Depression symptoms assessed with the Hospital Anxiety and Depression Scale;	3 to 24 months
Posttraumatic stress symptoms	Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised	3 to 24 months
Time to return to work or studies	Time to return to work or studies after COVID-19	3 to 24 months
Healthcare utilization	Medical and rehabilitation appointments, medication use and diagnostic tests	3 to 24 months
Costs	Individual health-related and COVID-19-related costs	3 to 24 months

Collaborators and Investigators

• Sponsor: Inova Medical
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2023/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be disclosed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No